Theophylline Tablets IP

1. Product Introduction

Theophylline is a methylxanthine bronchodilator used in selected patients with asthma and chronic obstructive pulmonary disease (COPD). The supplied composition confirms an uncoated Theophylline IP 200 mg tablet. It has a narrow therapeutic index and is generally not a first-choice treatment when safer inhaled therapies are suitable. It is not a rescue medicine for sudden breathlessness.

Healthy Life Pharma Pvt. Ltd. and Healthy Inc are identified as manufacturer and exporter in the supplied material. Facility approvals, WHO-GMP status, specific production capabilities and export permissions should be checked against current documentation.

2. Product Specifications

3. Manufacturing Technology

Theophylline tablet manufacture requires validated blending, content uniformity, compression and disintegration/dissolution testing. Because theophylline has a narrow therapeutic index, consistent dose delivery is important. The supplied 200 mg tablet is described as uncoated; sustained-release matrix technology, 12–24-hour release and special SR coating must not be attributed to this product without approved formulation evidence.

4. Quality Assurance

Quality controls should be based on the registered IP specification, including identification, assay, dosage-unit uniformity, dissolution or disintegration as applicable, impurities and stability. Release limits must follow the approved monograph and validated methods; the numeric limits quoted in general background text cannot be assumed to apply to this specific batch or formulation.

5. Therapeutic Uses and Mechanism

Theophylline promotes bronchodilation through several mechanisms, including phosphodiesterase inhibition and adenosine-receptor antagonism. It may be prescribed as an adjunct in selected patients with asthma or COPD when clinically appropriate. Modern inhaled therapies are usually preferred. Theophylline does not rapidly treat acute asthma attacks. It is not primarily an antitussive medicine.

6. Export and Regulatory Support

For B2B registration, request the approved composition, manufacturing license, current GMP evidence, product specification, stability data, certificate of analysis and market-specific regulatory documents. CTD/ACTD, COPP and FSC availability must be confirmed for the specific product and destination market. Packaging and shipping conditions should follow validated stability data.

7. Frequently Asked Questions

Q: Which strength is confirmed?
A: Theophylline IP 200 mg per uncoated tablet.

Q: Is this a sustained-release tablet?
A: Not confirmed. The supplied primary composition says uncoated tablet; release type should be verified from the approved label.

Q: Can it relieve an asthma attack immediately?
A: No. Follow an emergency asthma action plan and use prescribed rescue treatment.

Q: Does smoking affect theophylline?
A: Yes. Starting or stopping smoking can change blood concentrations; a clinician may need to reassess dose and monitoring.

8. Dosage and Administration

Prescribers individualize the dose according to formulation, age, body weight, comorbidities, interactions and serum theophylline concentrations. The 200 mg tablet strength is not a universal recommended dose. Therapeutic drug monitoring may be needed, especially when starting treatment, changing dose, becoming ill or changing smoking status. Follow the approved product label. Do not substitute immediate-release and sustained-release products or change the schedule without clinical advice.

9. Side Effects and Precautions

Common adverse effects include nausea, vomiting, headache, insomnia, tremor and palpitations. High concentrations may cause dangerous heart rhythm disturbances and seizures. Seek urgent care for severe vomiting, marked agitation, rapid or irregular heartbeat, or seizures. Theophylline interacts with medicines such as ciprofloxacin, certain macrolides and cimetidine; changes in smoking, fever and liver function may also alter clearance. Serum monitoring and interaction review are important.

10. Storage Instructions

Keep tablets in their original packaging in a dry place, protected from excess heat and moisture. Follow the exact temperature limit and expiry date stated on the approved product label; a specific shelf life cannot be confirmed from the supplied composition. Keep out of reach of children.